BEUDAMED
    FDA Recall Open, Classified

    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

    Recall: Z-2116-2025 · Initiated June 3, 2025

    Recall

    Recall Number
    Z-2116-2025
    Event Number
    96903
    Firm
    ICU Medical, Inc.
    FEI Number
    2025816
    Product Code
    QBP
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 3, 2025
    Posted
    July 11, 2025
    Address
    951 Calle, Amanecer San Clemente, CA, 92673-6212

    Description

    SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

    Reason

    Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.

    Action

    On 6/3/2025, correction notices were mailed and emailed to customers who were asked to do the following: 1) Inform all potential users of the product in your organization of this notification. 2) Discard the affected devices following your institution's process for discarding product. If discarding the device is not immediately possible at your facility, the device should be quarantined until disposal is possible. 3) Complete and return the Customer Response Form to [email protected] 5. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. For further inquiries, please contact firm at the following: Global Complaint Management, [email protected],1-(866)-216-8806; Customer Service, [email protected], 1-(800)-258-5361; Field Action Processing, [email protected], 1-(866)-328-0114

    Distribution

    Worldwide - US Nationwide distribution including in the states of TX, SD, ID, LA, IN, CO, OK, MO, MN, OR, AZ, NC, TN, VA, CA, IL, FL, MA, OH, MD, PA, NJ, NY, WA, GA, UT, MI, MS, AR, AL, NV, KS, IA, WV, HI, KY, NM and the country of CA.

    Quantity

    1,445,600